Court Finds FDA Played Politics with Emergency Contraception

NEW YORK, March 24 -- Politics, not science, led the FDA to delay approval of the emergency contraceptive Plan B and when the agency finally did okay the morning-after pill, politics dictated the access it allowed.

The U.S. District Court for the Eastern District of New York has given the FDA 30 days to review its decision regarding Plan B and to remove access restrictions.

The FDA, which approved Plan B for OTC and prescription sales in August 2006, delayed approval for three years, the court ruled.

The FDA said Plan B could be sold without a prescription only to women 18 or older, but younger women needed a prescription.

Moreover, the agency said the drug could only be sold as a behind-the-counter product, rather than being displayed openly on store shelves.

In its ruling, the court ordered the FDA to allow 17-year-olds to buy the drug without a prescription.

Plan B, consists of two pills, both of which contain 0.75 mg of a single active steroid ingredient, levonorgestrel [18,19-Dinorpregn-4-en-20-yn-3-one-13-ethyl-17-hydroxy-, (17Î±)-(-)-], a totally synthetic progestogen.

To obtain optimal efficacy, the first tablet should be taken as soon as possible within 72 hours of intercourse. The second tablet must be taken 12 hours later.

The drug is believed to act by preventing ovulation or fertilization by altering tubal transport of sperm or ova. It may also inhibit implantation by altering the endometrium. It is not effective once the process of implantation has begun.

The Bush administration, which was vocal in its opposition to abortion, was opposed to FDA approval of Plan B, but framed its opposition as a safety concern.

During the three years that the FDA delayed approval, Plan B became a flash point between the Bush administration and family planning groups.

As the years dragged on, those groups and leading women's organizations stepped up lobbying efforts until finally the Senate threatened to delay confirmation of Andrew von Eschenbach, M.D., as FDA commissioner pending approval of Plan B.

In its ruling, the court said it was that threat that finally forced the FDA to act on Plan B.

Accessibility Statement

At MedPage Today, we are committed to ensuring that individuals with disabilities can access all of the content offered by MedPage Today through our website and other properties. If you are having trouble accessing www.medpagetoday.com, MedPageToday's mobile apps, please email legal@ziffdavis.com for assistance. Please put "ADA Inquiry" in the subject line of your email.